Therapeutic Tooth Bud Ablation

ABSTRACT

An ablation procedure. The ablation procedure may be applied to tooth buds and result in tooth agenesis. The ablation procedure may be applied to lesions or tumors. A method for using a tooth bud ablation system in a tooth bud ablation procedure for ablating a tooth bud, said tooth bud having a middle, said procedure resulting in the agenesis of said tooth. The tooth may be a third molar in a human patient. A method for creating a third molar tooth bud ablation system including a custom surgical stent and an ablation probe tip for use in a third molar tooth bud ablation procedure that results in the agenesis of a third molar in a human patient.

The present application is a continuation of U.S. patent applicationSer. No. 13/093,842, filed Apr. 26, 2011, which is a continuation ofU.S. patent application Ser. No. 12/863,183, filed Jul. 15, 2010 (whichissued as U.S. Pat. No. 9,402,693 on Aug. 2, 2016), which is a nationalstage filing under 35 U.S.C. 371 of International Application No.PCT/US10/34259, filed May 10, 2010, which is an internationalapplication claiming the benefit under 35 U.S.C. Section 119(e) of U.S.Provisional Patent Application Ser. No. 61/177,143, filed May 11, 2009.The present application is also a continuation of U.S. patentapplication Ser. No. 13/093,844, filed Apr. 26, 2011, which is acontinuation of U.S. patent application Ser. No. 12/863,183, filed Jul.15, 2010 (which issued as U.S. Pat. No. 9,402,693 on Aug. 2, 2016),which is a national stage filing under 35 U.S.C. 371 of InternationalApplication No. PCT/US10/34259, filed May 10, 2010, which is aninternational application claiming the benefit under 35 U.S.C. Section119(e) of U.S. Provisional Patent Application Ser. No. 61/177,143, filedMay 11, 2009. The present application is based on and claims priorityfrom these applications, the disclosures of which are hereby expresslyincorporated herein by reference in their entirety.

COPYRIGHT NOTICE

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction of the patent disclosure as itappears in the Patent and Trademark Office patent files or records, butotherwise reserves all copyright rights whatsoever.

TECHNICAL FIELD

Described herein are a tooth bud ablation (TBA) procedure and a toothbud ablation (TBA) system.

BACKGROUND ART

Approximately 3.5% of the total $100 billion spent on dental care in theUnited States in 2008 was for traditional surgical removal of thirdmolars (i.e. “wisdom teeth” extractions), including the associated costsof imaging, sedation, and resulting complications. Traditional surgicalremoval of third molars, however, is a highly invasive, painful, andcomplication-ridden procedure. Further, third molar extractionrepresents the only procedure in the United States and Europe where itis considered “normal” to subject patients of any age group to such ahighly invasive prophylactic surgery that carries significant lifelongrisks for the excision of asymptotic or non-pathologic tissue. Dentalpractitioners (e.g. general dentists, pediatric dentists, and oralsurgeons) have been trained to remove children's wisdom teeth (thirdmolars) before the wisdom teeth cause problems, but this surgery carriessignificant pain, risks, and costs.

The main problem associated with third molar tooth extractions—asidefrom the pain inflicted—is the serious risk of complications associatedwith such an invasive procedure. Each year “more than 11 million patientdays of ‘standard discomfort or disability’ —pain, swelling, bruising,and malaise—result post-operatively, and more than 11,000 people sufferpermanent paraesthesia—numbness of the lip, tongue, and cheek—as aconsequence of nerve injury during the surgery. At least two thirds ofthese extractions, associated costs, and injuries are unnecessary,constituting a silent epidemic of iatrogenic injury that afflicts tensof thousands of people with lifelong discomfort and disability.”

If you interview people under the age of 40 and ask them what has beenthe most invasive surgical procedure they have personally experienced(that is not trauma related), there is a greater than 90% chance that itwill be their “wisdom teeth” extraction. The current standard of care inAmerica for “managing” third molars (e.g. “wisdom teeth”) in adolescentsand young adults is generally to have all four third molars extractedonce they are formed, unless it is absolutely clear that these teethwill erupt normally. General dentists and oral surgeons alike arecomplicit in their belief that third molars generally should beextracted because not all will erupt normally, thus causing futurepathology.

Each year, an estimated 10 million third molar tooth extractions accountfor over 92% of all teeth extracted for patients under the age of 40.This represents surgery on approximately 5 million people each year atan estimated cost of over $2.5 billion for third molar extraction feesalone in the United States. When IV sedation fees, X-ray imagingexpenses, post-op medications, and unplanned post-operative expensesassociated with treating complications are added in, the true UnitedStates health care cost is estimated to be well over $3.5 billion. Inaddition to fee inflation, it has been shown that “upcoding” of wisdomteeth extraction (i.e. using an insurance code for payment of a higherfee than is clinically justified) has become an increasing problem forinsurers. Insurance claims patterns clearly show that this procedure islargely treated as an elective procedure. The average annual income peroral surgeon has been estimated to be approximately $500,000 for thirdmolar extraction fees alone. Insurance companies have historicallyreported that reimbursement for third molar extractions has been thehighest reimbursed surgical procedure—even higher than hysterectomies inyears when medical insurance used to pay for both procedures.

The market demographics and associated expenses are compelling. Over 77%of children at age 6 have all four third molar tooth budsradiographically detectable on routine panographic X-rays (a type ofvolume scan). Over 90% of all teenagers in the United States have atleast one third molar that will fully form. A typical cost for an oralsurgeon to remove all four third molars on a teenager is generally$2,000 to $2,500 per patient once the teeth have at least partiallyformed—but before they have erupted —including the cost of IV sedation,consultations, and X-ray imaging costs.

There has been considerable controversy for the past fifty yearsregarding prophylactic extraction of third molars. A number of leadingauthorities have objectively tried to demonstrate that prophylacticextraction is a waste of healthcare dollars, citing studies thatindicate there is no objective scientific evidence for such a procedure,while other groups vigorously argue that prophylactic extraction in theteens and early adult years greatly eliminates more serious problemslater in life and is worth the cost and risk.

An important question to ask is, “What happens if no prophylactic thirdmolar extractions occur?” For instance, “as many as 22% of all emergencydepartment visits” at a United States military support facility wererelated to dental problems, most of which were third-molar specific. Inthird-world countries, where prophylactic extraction of wisdom teeth issimply not performed, a high percentage of patients will present withacute infections, decay, gum disease and other problems later in life.In Jordan—where prophylactic extraction is not performed—46% of adultpatients had pathology (decay, infection, bone loss, etc.) detectable ontheir third molars on routine X-rays and volume scans. Numerous studiesshow that third molars are hard to clean, generally do not erupt fully,and are the single most-likely teeth to have problems associated withthem.

Routine panographic X-rays of adults taken during a random two-weekperiod are shown in FIGS. 1 and 2. These X-rays show the examples of therange of problems that adult patients experience when they have thirdmolars that are not extracted at an early age, including advanced decayand gum infections. For example, FIG. 1 shows a 48-year-old patient withboth upper third molars present. There is a gum infection around boththird molars that has caused 90% of the bone on the distal side of thesecond molars to be destroyed. In order to save the first molars,extraction of the second and third molars on the upper-arch will benecessary. FIG. 2 shows another example in which a 36-year-old patienthas all four third molars present. The upper third molars arehyper-erupting because they have no opposing teeth to occlude against.They will eventually need to be extracted. The lower third molars arehorizontally impacted and show no signs of infection, but if they becomeinfected, then the patient will almost certainly loose the adjacentsecond molars because of the bone damage that will occur.

The problem all practitioners face is that it is practically impossibleto tell in advance which impacted wisdom teeth will ultimately causefuture pathology. The reality is that most wisdom teeth (well over 50%)are surgically extracted prophylactically with no real knowledge thatthey will actually cause future pathology.

If pathology appears in patients over the age of 40, however, the stakesare much different. According to two prospective studies in the UnitedStates, in 1997 10.5% and in 2002 17.3% of patients requiring thirdmolar extractions were over the age of 40. If a patient is presentinglater in life to have one or more third molar extracted, it is becauseactive pathology has been diagnosed, making surgery no longer elective.The attendant complication rates are not just higher, but these patientswere categorized as “very high risk patients” for surgery. These studiesconcluded, “[t]he risk to patients and to the profession can bedramatically reduced by considering early removal of abnormal thirdmolars” and “based on our experience, we propose extraction of thirdmolars during adolescence when the X-ray indicates normal eruptioncannot be expected due to lack of space or an abnormal position.”

The occurrence of post-operative complications is generally consideredto be over 15% by most independent researchers. For instance, theformation of long-term periodontal pockets on the distal surfaces ofsecond molars that results in gum disease, infection, and eventualsecond molar tooth loss is estimated to be over 10% due to the damageand poor bone morphology that result from third molar extractionsurgery. The incidence of post-operative infections and “dry sockets” isgenerally accepted to be over 15%. Temporary paraesthesia due to damageto the mandibular nerve or the lingual nerve is over 10%, with residualpermanent numbness of the lip or tongue present in approximately 1.5% ofall patients. Recently, it has been concluded that approximately 23% ofall cases of long-term Temporomandibular Joint (“TMJ”) dysfunction andchronic joint pain are attributable to third molar extraction surgeries.

Malpractice claims against dental practitioners relating to third molarextractions are at an all time high. Litigation for residual TMJproblems is increasing; in 2002 a North Carolina jury awarded $5 millionin damages to a patient with TMJ pain following third molar extractions.The incidence of litigation over permanent numbness of the lip hasdramatically increased in recent years. Malpractice claims withresulting payouts have been reported to be as high as two-thirds of allclaims made against dental practitioners when nerve damage is involved.

If the wisdom teeth are not extracted in adolescence, the roots willfully form, making future extraction difficult and dramaticallyincreasing the incidence of serious complications if surgery shouldlater be required. The damage induced by long-standing, chronicinfections in adults may necessitate the extraction not only of thethird molars when they become symptomatic, but also of the adjacentsecond molars. Additional complications include the reduced healingresponse of adults as compared to adolescents, and the economic hardshipinduced by having to miss work. Many references indicate thatprophylactic extraction of third molars in teens and young adults —inspite of the possibility of lifelong complications such as nervedamage—is justified to avoid the non-elective third molar extraction inadults over the age of 30.

Complications can be severe, even requiring hospitalization when teethhave been extracted on an out-patient basis. There have even beenreports of patients who died as a direct result of wisdom toothextractions.

As an example, FIG. 3 is an X-ray showing a 9-year-old patient with fourthird molar tooth buds present; three of them are in very early stagesof enamel formation. The lower right third molar tooth bud does not haveenamel formed yet, but will shortly. This X-ray shows an example of theearly stages in which the tiny third molar tooth buds begin to form,begin to develop enamel, and finally begin to develop roots. Early signsof problems are almost always clearly evident by the time a patient is ateenager.

Once the tooth starts to form, the tooth bud starts to become encased inbone and appears to be “pushed down” into the mandible and maxilla asthe child's jaw bone grows out and around the tooth bud with age. Futuresurgical access becomes far more invasive as the bone encases theforming third molar. Given the basic physiology involved, earlyintervention is the only approach that will eliminate the complicationsand high costs associated with extraction of fully formed third molarslater in life.

The idea of prophylactic third molar tooth bud removal is not new. In1936, Dr. Henry supported the surgical enucleation of tooth buds, and itwas again supported in the mid 70s by several practitioners usingsomewhat invasive surgical techniques to physically access the toothbuds and mechanically cut them out. In 1979, Drs. Gordon and Laskin usedcryoprobes to enucleate third molar tooth buds in dogs. However, at theNIH Conference On Third Molars in 1979 it was concluded that “[a]lthoughthere are cogent reasons for early removal of third molars, the groupfelt that the suggested practice of enucleation of third molar toothbuds, based on predictive studies at age 7 to 9, is not currentlyacceptable.” (National Institutes of Health—Removal Of Third MolarsConsensus Development Conference Statement—1979.)

Early removal of partially formed third molars (sometimes referred to asa “germectomy”) where the enamel of the crown has completely formed butless than one-third of the root length has formed, is demonstrated to besomewhat less invasive and carries no demonstrated long-termcomplications or risks associated with early-stage surgery. However, itis still highly invasive and generally requires IV sedation of theteenage patient. The American Association of Oral & MaxillofacialSurgeon's White Paper On Third Molar Data references five studiesinvolving over 1,100 germectomies with not a single case of a long-termcomplication (nerve injury, etc.) associated with the surgery. Further,since the germectomies were carried out on teenagers, there were noeconomic hardships induced by missing work. The White Paper understatesthe obvious conclusions associated with early intervention: “It doesappear that early third molar removal may be associated with a lowerincidence of morbidity and also less economic hardship from time offwork for the patient.” However, it can also be concluded that there is atremendous conflict of interest because this paper was written by oralsurgeons. To date there is still no measurable shift by dentalpractitioners to change the way in which third molars are screened,diagnosed, and extracted (i.e. early extraction), indicating that thereis a need to fundamentally change the way this condition is beingsurgically managed.

There are a number of existing alternative technical approaches that canbe considered for prophylactic enucleation of third molar tooth budsbefore the crown or root begins formation in children age 6 to 10. Thesetechnical approaches include ablation procedures using different typesof ablation means. Exemplary ablation procedures include electrosurgetissue ablation (rats), cryoablation (dogs), laser ablation (dogs), andthe use of a scalpel (humans). All but the first three ablationprocedures (microwave ablation, radio frequency ablation, andirreversible electroporation) have significant limitations due to beinghighly invasive, high in cost, requiring cumbersome equipment, or due tothe limited means of mechanical access in the oral cavity. Nor do theseablation procedures offer the potential for real-time feedback controlto contain collateral tissue damage. To date, the only documented trialof any form of tooth bud ablation procedure utilizing ablationtechnology that is currently used in mainstream medicine is cryoablation(although preliminary animal trials have been completed usingelectrosurgical power and lasers).

The article entitled “Selectively Preventing Development Of Third MolarsIn Rats Using Electrosurgical Energy” by Silvestri et al. describes apilot study that tests the hypothesis that third molars can beselectively prevented from developing. To test the hypothesis, a studywas conducted in which thirty-three neonate rats receivedelectrosurgical energy to the mucosal surfaces of one of their maxillarytuberosities. In this study, guides (insulating plastic positioningdevices that housed the electrosurgical probes) were used. The guideswere fabricated using the mouths of euthanized rat pups of the same ageas the rats that were to be treated as a mold for creating the guides.Then, the electrosurgical probe placed so that its stainless steel tipextended less than 1.0 mm beyond the plastic positioning device toensure contact with the external surface of the oral mucosa of themaxillary tuberosity. Finally, when in position, the rat pups received asingle, unilateral, momentary pulse of monopolar electrosurgical energyto the external surface of the gum tissue of their maxillary tuberosityregions. It should be emphasized that this surface application ofelectrosurgical energy acted first to unnecessarily kill the overlyinggum tissue, then bore a hole through the gum tissue, and otherwisedamage not only the tooth buds, but other nearby tissue. The rats werecared for, but after the experimental period, were euthanized todetermine the effectiveness of the procedure. The results were that tenrats showed no intra-oral or radiographic evidence of third molardevelopment (and most of these rats subsequently developed palataldeformities), and six developed smaller-than-normal third molars. Theconclusion was that maxillary third molars could be selectivelyprevented from developing in rat pups at or near the time of tooth budinitiation. It was recognized, however, that electrosurgical energy wastoo powerful and uncontrollable to reliably confine its damage to onlythe tooth-forming tissues.

SUMMARY OF THE INVENTION

Described herein is a tooth bud ablation procedure that results in toothagenesis, including the steps of: (a) physically seating a customsurgical stent having at least one surgical guide so the at least onesurgical guide corresponds to at least one tooth bud surgical site; (b)using the at least one surgical guide, making a surgical access path atthe at least one tooth bud surgical site; (c) using the at least onesurgical guide, guiding placement of an ablation probe tip having acenter of ablation so that the center of ablation is in the middle of atooth bud at the at least one tooth bud surgical site; and (d) at leastpartially ablating at least one tooth bud.

Described herein is a tooth bud ablation system for use in a tooth budablation procedure that results in tooth agenesis, the system including:(a) a custom surgical stent with at least one surgical guidecorresponding to at least one tooth bud surgical site; (b) an ablationprobe tip having a center of ablation; and (c) the at least one surgicalguide having structure for guiding placement of the ablation probe tipso that the center of ablation is in the middle of a tooth bud byinserting the ablation probe tip through the at least one surgicalguide.

Described herein is an ablation procedure including the steps of: (a)physically seating a custom surgical stent having at least one surgicalguide so the at least one surgical guide corresponds to at least onelesion or tumor surgical site; (b) using the at least one surgicalguide, making a surgical access path at the at least one lesion or tumorsurgical site; (c) using the at least one surgical guide, guidingplacement of an ablation probe tip having a center of ablation so thatthe center of ablation is in the middle of a lesion or tumor at the atleast one lesion or tumor surgical site; and (d) at least partiallyablating at least one lesion or tumor.

Described herein is an ablation procedure including the steps of: (a)physically seating a custom surgical stent having at least one surgicalguide so the at least one surgical guide corresponds to at least onelesion or tumor surgical site; (b) using the at least one surgicalguide, guiding placement of an ablation probe tip having a center ofablation so that the center of ablation is in the middle of a lesion ortumor at the at least one lesion or tumor surgical site; and (c) atleast partially ablating at least one lesion or tumor.

Described herein is a method for volume scanning both hard tissues andsoft tissues of a patient, the method including the steps of: (a) usingan impression of a material visible in a volume scan; (b) generating avolume scan in which hard tissue is visible and the impression isvisible, and soft tissue being “visible” as the space between thevisible hard tissue and the visible impression; and (c) providingresults of the step of generating a volume scan for the purpose ofmanufacturing or fabricating a custom surgical stent having at least onesurgical guide for guiding placement of an ablation probe tip.

Described herein is a method for simultaneous volume scanning of bothhard tissues and soft tissues, the method including the steps of: (a)using a dental impression of a material visible in a volume scan; (b)physically seating the dental impression in a patient's mouth; (c)volume scanning the patient's mouth while the dental impression isseated therein; (d) the step of volume scanning generating a volume scanin which hard tissue is visible and the dental impression is visible,and soft tissue is “visible” as the space between the visible hardtissue and the visible dental impression; and (e) providing the resultsof the step of volume scanning for the purpose of manufacturing orfabricating a custom surgical stent having at least one surgical guidefor guiding placement of an ablation probe tip.

Described herein is a method for manufacturing or fabricating a customsurgical stent, the method including the steps of: (a) using a volumescan image in which hard tissue is visible and a dental impression isvisible, and soft tissue is “visible” as the space between the visiblehard tissue and the visible dental impression; and (b) manufacturing orfabricating a custom surgical stent with at least one ablation probe tipguide for guiding at least one ablation probe tip to a pre-defined angleand depth of ablation based on information obtained from the volume scanimage.

Described herein is a tooth bud ablation procedure that results in toothagenesis, including the steps of: (a) pre-operatively takingmeasurements to determine a three-dimensional location of the middle ofa tooth bud; (b) placing an ablation probe tip having a center ofablation so that the center of ablation is in the three-dimensionallocation of the middle of a tooth bud; and (c) at least partiallyablating at least one tooth bud.

Described herein is a custom surgical stent for use in a tooth budablation procedure that results in tooth agenesis, the custom surgicalstent for use with an ablation probe tip having a center of ablation,the stent including: (a) a custom surgical stent with at least onesurgical guide corresponding to at least one tooth bud surgical site;(b) the at least one surgical guide having guiding structure to guideplacement of an ablation probe tip at a pre-defined angle so that acenter of ablation of the ablation probe tip is in the middle of a toothbud; and (c) the at least one surgical guide having mechanical stopstructure to limit the depth of the ablation probe tip to a pre-defineddepth.

The foregoing and other objectives, features, and advantages of theinvention will be more readily understood upon consideration of thefollowing detailed description of the invention, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated in and constitute a part ofthis specification.

FIG. 1 is an X-ray showing a 48-year-old patient with both upper thirdmolars present, the X-ray being presented to show examples of the rangeof problems that adult patients experience when they have third molarsthat are not extracted at an early age.

FIG. 2 is an X-ray showing a 36-year-old patient with all four thirdmolars present, the X-ray being presented to show examples of the rangeof problems that adult patients experience when they have third molarsthat are not extracted at an early age.

FIG. 3 is an X-ray showing a 9-year-old patient with four third molartooth buds present; three of them are in very early stages of enamelformation, but the lower right third molar tooth bud does not yet haveenamel formed.

FIG. 4 is a flow chart showing steps in preferred TBA proceduresincluding: (1) routine screening and diagnosis; (2) pre-surgicalimpressions and scanning; (3) assembling a TBA surgical kit; (4)operator delivery of the TBA procedure; and (5) follow-up.

FIG. 5 is a simplified block diagram of a TBA probe system, a customsurgical stent, and a tooth bud.

FIG. 6 is a cross-sectional side view of an ablation probe tip in theprocess of being inserted through a surgical guide of a stent.

FIG. 7 is a cross-sectional side view of an ablation probe tip insertedthrough a surgical guide of a stent into the tooth bud.

FIG. 8 is a cross-sectional side view of an ablation probe tip having alinear array of temperature sensors inserted in the tooth bud.

FIG. 9 is a cross-sectional side view of an ablation probe tip ablatingthe tooth bud.

FIG. 10 is a cross-sectional side view of an ablation probe tip beingremoved from the ablated tooth bud.

FIG. 11 is a flow chart showing the steps of a TBA procedure that resultin tooth agenesis.

FIG. 12 is a flowchart showing the steps that a software program formanufacturing or fabricating custom surgical stents 110 and defining(and/or computing or calculating) the pre-determined parameter settingsand/or treatment time settings.

FIG. 13 is a panographic X-ray showing a patient whose third molar toothbuds in the #17 and #32 positions are treatable by TBA.

FIG. 14 is a pre-operative cone beam computed tomography (“CBCT”) scanof a different patient.

FIG. 15 is a series of X-rays showing successive 1.0 mm slices throughboth #17 and #32 in 1.0 mm increments.

FIG. 16 is a perspective view from a front corner showing apre-operative upper-arch impression being taken of a simulated patient.

FIG. 17 is a cross-sectional view of an upper-arch impression beingtaken of a simulated patient.

FIG. 18 is a perspective view from above of the completed upper-archimpression.

FIG. 19 is a perspective view from above of the completed upper-archimpression, along with a stone model that will serve as a “positive” formanufacturing or fabricating of a custom surgical stent for thatpatient's upper-arch.

FIG. 20 is a CBCT scan with notations showing the measurement of theangle of entry into the tooth bud.

FIG. 21 is a series of X-rays with notations showing the measurement ofthe lateral angle of entry.

FIG. 22 is a CBCT scan with highlights showing the computed volume ofeach tooth bud.

FIG. 23 is a perspective view from above of a surgical stent with twosurgical guides, the stent having been manufactured or fabricated usingthe CBCT positioning information.

FIG. 24 is a perspective view showing topical anesthetic being appliedto the base of the surgical guide.

FIG. 25 is perspective view from a front corner of a surgical stentbeing seated on the upper-arch of the simulated patient.

FIG. 26 is a perspective view from a front corner of a local anestheticbeing injected into a tooth bud site.

FIG. 27 is a perspective view from a front corner of a tissue trocarbeing used to punch to the base of a tooth bud.

FIG. 28 is a perspective view from a front corner of an ablation probetip with a mechanical (physical) stop being positioned through thesurgical guide into the tooth bud.

FIG. 29 is a perspective view from a front corner of the ablation probetip being positioned in each tooth bud through the surgical guide sothat the ablation probe tip's effective center of ablation is in themiddle of each tooth bud.

DETAILED DESCRIPTION OF THE INVENTION

The highly invasive surgical procedure of extracting third molars can becompletely eliminated by prophylactically eliminating the small toothbuds that will eventually form the wisdom teeth. Children age 6 to 12will generally have radiographically detectable tooth buds with no signsof tooth formation inside the tooth bud. Third molar tooth bud agenesis(the lack of third molar formation) can only be conclusively determinedby age 14. Third molar tooth buds are lying just 2.0 mm to 3.0 mmbeneath the surface of the attached gingival (gum) tissue, making themaccessible for rapid anesthesia and minimally invasive ablation with thecorrect selection of soft tissue ablation and supporting scanning andstent-manufacturing technologies.

By successfully improving existing medical technology, the highlyinvasive, painful, and complication-ridden procedure of traditionalsurgical removal of third molars (i.e. “wisdom teeth” extractions) canbe replaced with a minimally invasive tooth bud ablation (TBA) procedure70 such as that shown in FIG. 4 that is risk free, painlesspost-operatively, and less expensive when compared to surgicalextractions.

The TBA procedure 70 (FIG. 4) and TBA system 100 (FIG. 5) for use in theTBA procedure 70 seek to achieve: (1) a minimally invasive procedureconsisting of a surgical access path at a surgical site (e.g. at eachtooth bud surgical site), (2) that can predictably ablate all four thirdmolar tooth buds 120 in thirty (30) minutes or less (including time toadminister anesthesia) using either microwave (“MW”) or radio frequency(“RF”) ablation, (3) that can be administered by dental practitionersunder normal office conditions, (4) with direct procedure costs reducedby 25% or more, and (5) with zero risks or complications when comparedto traditional surgical extraction of fully developed third molars. Itshould be noted that the TBA procedure 70 is shown and described as aprophylactic third molar tooth bud ablation (TMTBA), but it is notlimited thereto. For example, there may be supernumerary teeth thatshould not be in a patient's mouth (e.g. there may be two teeth #5), theremoval of which would not be prophylactic in nature.

One preferred advantage of the surgical phase 90 described herein isthat it is a minimally invasive surgical procedure. With a minimallyinvasive surgical procedure design coupled with electronic feedbackcontrols using MW and RF ablation technology to limit soft tissuedamage, performing this procedure on children aged 6-12 years old takesapproximately thirty (30) (or fewer) minutes, including the time toadminister local anesthetics.

Another preferred advantage of the surgical phase 90 described herein isthat it will not accidentally disrupt adjacent second molar toothdevelopment, even though the formation of second molars are well underway because these tooth buds 120 have started to form before birth. Theuse of relatively new scanning technologies (e.g. computed tomographyvolume scanning such as cone beam computed tomography (CBCT) scanningand MRI volume scanning) and accurate custom surgical stents 110 toguide ablation probe tip 108 placement will eliminate the risk ofaccidentally disrupting the second molars by minimizing collateraltissue damage.

Summarily, the TBA procedure 70 (FIG. 4) preferably includes a screeningphase 72, a pre-surgical phase 80 (also referred to as TBA pre-surgicalphase 80) that includes pre-surgical scanning 82 and the assembling of aTBA surgical kit 88 (that includes pre-determined settings 105 as wellas a surgical stent 110), a surgical phase 90 (also referred to as TBAsurgical phase 90), and a follow-up phase 98.

A TBA system 100 (FIG. 5) is preferably used during the surgical phase90 (shown graphically in FIGS. 6-10 and as a flow chart in FIG. 11) ofthe TBA procedure 70. Summarily, the TBA system 100 includes a TBA probesystem 101 (including a generator 104 capable of emitting one or moretypes of ablation means 104′, a hand piece 106, and an ablation probetip 108) and at least one surgical stent 110 (which was manufactured orfabricated during the pre-surgical phase 80). Each stent 110 has atleast one surgical guide 112 to guide the placement of the ablationprobe tip 108 so that its center of ablation 130 a is placed into themiddle of the tooth bud 130 b. This is accomplished by positioningablation probe tip 108 through the surgical guide 112 at a pre-definedangle and depth using a mechanical relationship of the ablation probetip 108 and the surgical guide 112 to form a “stop” therebetween. FIGS.6-10 show (and FIG. 11 describes) the procedure of inserting theablation probe tip 108 through the surgical guide 112 of a stent 110,ablating the tooth bud 120, and removing the ablation probe tip 108 fromthe ablated tooth bud 120′.

The TBA System 100

The TBA system 100 described herein is the system that is used duringthe surgical phase 90 of the TBA procedure 70. Some of the components(e.g. the custom surgical stent 110 and the pre-determined settings 105)used in the TBA system 100 are part of the TBA surgical kit assembledduring the pre-surgical phase 80.

The TBA system 100, as shown in FIG. 5, includes a TBA probe system 101(including a generator 104, a hand piece 106, and an ablation probe tip108) and at least one surgical stent 110 (each stent 110 has at leastone surgical guide 112 to guide (direct) the placement of the ablationprobe tip 108 to the middle of the tooth bud 130 b). The generator 104and the hand piece 106 may be jointly referred to as the ablation probeunit 102 (or the programmable ablation probe unit 102). The generator104 and hand piece 106 may be integral or functionally connectedtogether. The generator 104 (and/or the ablation probe unit 102) may beprogrammed with pre-determined parameter settings 105 a and/or treatmenttime settings 105 b (referred to jointly as pre-determined settings105). The generator 104 (and/or the ablation probe unit 102) provides anablation means 104′ for ablating the tooth bud 120 based on thepre-determined settings 105. Central to the TBA system 100, is theinteraction between the ablation probe tip 108 and the surgical stents110 (and specifically the surgical guides 112).

Generator 104

The generator 104 provides the ablation means 104′ suitable for ablatinga tooth bud 120 during the surgical phase 90 of the TBA procedure 70. MWenergy and RF energy are discussed as exemplary preferred ablation means104′. Another alternative preferred ablation means 104′ is irreversibleelectroporation because it has subsecond activation times that canreduce collateral tissue damage. Yet another alternative preferredablation means 104′ include, but are not limited to, cryoablation,ultra-high intensity ultrasound, laser, chemical, thermal or hot tip(e.g. a tip having any source of heat including, but not limited to, alight bulb, a soldering iron, or steam heat), and/or mechanical means.These ablation means 104′ may also be combined either simultaneously orconsecutively. It should also be noted that other known andyet-to-be-developed ablation means 104′ may also be used. It should benoted that although discussed primarily in terms of MW and RF, unlessspecifically set forth otherwise, the use of other ablation means 104′is possible.

The generator 104 (alone or as part of an ablation probe unit 102) maybe programmed by the operator and/or at the laboratory and/or factoryand may be accomplished automatically or manually. The programming ofthe generator 104 may include programming at least one pre-determinedsetting 105.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred generators 104.

-   -   Preferred generators 104 may be multi-use devices designed as        110V counter-top units.    -   Preferred generators 104 may be MW/RF generators with output        levels determined initially through finite element analysis        models or experimentally derived functions that exist for tumor        ablation.    -   Preferred generators 104 (and/or ablation probe units 102) may        have operator input mechanisms (e.g. knobs, dials, key pads,        keyboards, I/O interfaces, connections to the internet, or other        means for inputting or programming) in which the operator inputs        (or allows input of) the pre-determined settings 105.    -   Preferred generators 104 (and/or ablation probe units 102) may        have output mechanisms 103 (e.g. a display or audio) for        providing setting feedback (e.g. calibration cycles and        pre-determined settings 105), warning feedback (e.g. to prevent        operator mishandling), and intra-operative feedback on the        progress of the procedure such as time remaining (e.g. a count        down or a series of beeps to alert the operator to procedure        completion) and/or temperature (e.g. to alert the operator to        overheating).    -   Preferred output displays may be digital readout displays (that        may be color and/or in a large format) that permit the operator        to easily see feedback intra-operatively from across a standard        dental operatory (approximately 6-8 feet viewing distance).

Hand Piece 106

The hand piece 106 is the functional intermediary between the generator104 and the ablation probe tip 108. The hand piece 106 may be connectedsubstantially at one end to the generator 104. Substantially at theother end of the hand piece 106, opposite the generator 104, the end ofthe hand piece 106 (the surgical end) is adapted to accept the ablationprobe tip 108. The hand piece 106 is preferably detachable from thegenerator 104 (if they are not an integral unit) and the ablation probetip 108 is preferably detachable from the hand piece 106.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred hand pieces 106.

-   -   Preferred hand pieces 106 preferably hold or secure an ablation        probe tip 108 by latching the ablation probe tip 108 into the        hand piece head. In some hand pieces 106, the ablation probe tip        108 latches into the hand piece head at an angle (e.g. a 90        degree angle). It should be noted that the terms “latching” and        “latch” are used to describe any type of secure fit including,        but not limited to, clipping, snapping, or holding.    -   Preferred hand pieces 106 preferably have a hand piece head        (attached or integral) that is at an approximately 20 degree        angle to the rest of the hand piece. This bend emulates a        standard dental high-speed hand piece to facilitate easy access        of both upper and lower surgical sites. In some preferred hand        pieces 106, the 20 degree bend can be adjusted intra-operatively        to permit improved operator access to both upper- and        lower-arches.    -   Preferred hand pieces 106 preferably are rapidly detachable from        the generator 104. Preferably the connectors are ultra-reliable        for repeated removal/attachment from the generator 104.    -   Preferred hand pieces 106 are preferably fully steam        autoclavable. Alternative preferred hand pieces 106 are        disposable or have disposable covers.    -   Preferred hand pieces 106 preferably have actuators to allow        operator activation. The actuators may be separate from the hand        pieces 106 or integral therewith. Exemplary actuators include,        but are not limited to a wireless foot control or a        hand-operated switch on the hand piece 106.    -   The hand piece 106 may be integral with the generator 104 to        form a hand-held integrated generator unit (hand-held integrated        ablation probe unit).

Ablation Probe Tip 108

One end of the ablation probe tip 108 has structure suitable forconnecting it to the hand piece 106. The ablation means 104′ flows fromthe generator 104 through the ablation probe tip 108 and out to a centerof ablation 130 a (the focal point of the ablation). The ablation probetip 108 is insertable through the surgical guide 112, through thegingival tissue 122, and into the middle of the tooth bud 130 b. Thecenter of ablation 130 a is at the insertion end of the ablation probetip 108 such that when the insertion end of the ablation probe tip 108is positioned at the pre-defined angle (φ) and pre-defined depth (x)during the surgical phase 80, the center of ablation 130 a substantiallycoincides with or overlaps the middle of the tooth bud 130 b.

The pre-defined angle (φ) is the angle at which the ablation probe tip'seffective center of ablation 130 a is in the “middle” of the tooth bud130 b as calculated (during the pre-surgical phase 80) as describedherein or using an alternative method. The pre-defined depth (x) is thedepth at which the ablation probe tip's effective center of ablation 130a is in the “middle” of the tooth bud 130 b as calculated as describedherein or using an alternative method. The phrase “middle of the toothbud 130 b” is meant to include the three-dimensional area within thetooth bud 120 and, in particular, the three-dimensional area within thetooth bud 120 that is more towards the absolute middle point thantowards the outer periphery of the tooth. The pre-defined angle (φ) andpre-defined depth (x) can also be referred to as the “calculated angleand depth,” the “prescribed angle and depth,” the “proper angle anddepth,” the “correct angle and depth,” the “optimal angle and depth,” orthe “ideal angle and depth.”

The ablation probe tip 108 includes a mechanical stop structure 140(e.g. a band, protrusion, or shoulder) designed to physically limit thedepth of the ablation probe tip 108 when used in conjunction withmechanical stop structure 142 (e.g. the upper surface, a protrusion onthe upper surface, or a notch in the upper surface) of the surgicalstent 110 and/or surgical guide 112. In other words, the mechanical stopstructure 142 of the surgical guide 112 and the mechanical stopstructure 140 of the ablation probe tip 108 together limit how much ofthe ablation probe tip 108 can pass through the surgical guide 112 untilthere is a mechanical stop between the mechanical stop structure 142 ofthe surgical guide 112 and the mechanical stop structure 140 of theablation probe tip 108.

Each ablation probe tip 108 may be individually custom made (e.g.manufactured or fabricated) or may be selected from a family of ablationprobe tips 108 (i.e. there may be a “family” of probe tips 108 that willcover all clinical possibilities for tooth bud diameters and depths). Inthe manufacturing or fabricating of the surgical stents 110, however,the characteristics of the ablation probe tip 108 (custom made orselected) that may be taken into consideration include, for example,length, shape, angle, position of a mechanical stop structure 140,diameter, and size, shape, and location of the center of ablation 130 a.For example, if a particular ablation probe tip 108 had mechanical stopstructure 140 (shown as the bottom surface of an annular ring orshoulder in FIGS. 6-10 and 28-29) is 10.0 mm from the absolute tip ofthe ablation probe tip 108 (and the center of ablation 130 a issubstantially adjacent to the absolute tip), but the center of ablation130 a was only 8.0 mm from the surface of the gingival tissue 122 (shownas (x) in FIG. 6), then the surgical guide 112 would have to be 2.0 mmthick (shown as (y) in FIG. 6). On the other hand, if all surgicalguides 112 being made by the procedure were exactly 0.5 mm thick, theablation probe tip 108 would either have to be made or selected so thatthe mechanical stop structure 140 is 2.5 mm from the center of ablation130 a of the ablation probe tip 108. The appropriate ablation probe tip108 preferably will result in the intra-operative placement of theeffective center of ablation 130 a of the ablation probe tip 108 intothe targeted middle of the tooth bud 130 b±0.5 mm.

The ablation probe tips 108 may be sharp enough and/or may be strongenough so that the ablation probe tips 108 can be “self-introducing” inthat the ablation probe tips 108 can be pushed through the gingivaltissue 122. Alternatively, if tissue trocars 146 (described herein) areto be used, the ablation probe tips 108 would not have to be as sharpand/or strong.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred ablation probe tips 108.

-   -   Preferred ablation probe tips 108 are preferably disposable        (e.g. single-use).    -   Preferred ablation probe tips 108 may be specially designed to        work with the specific ablation means 104′ produced by the        generator 104. Other preferred ablation probe tips 108 may be        designed to work with multiple types of ablation means 104′        produced by the generator 104 or generators 104.    -   The design of the ablation probe tip 108 may be dependent on the        physics involved with transmitting ablation means 104′ through        the smallest possible diameter with an ideal maximum diameter.        For example, an MW/RF ablation probe tip may be designed for        transmitting MW/RF energy through the smallest possible diameter        with an ideal maximum diameter of 0.5 mm to 1.0 mm targeted.    -   The “family” of probe tips 108 may include probe tips 108 having        a variety of characteristics. For example, the family might have        probe tips 108 of different lengths ranging from 5.0 mm to        20.0 mm. This range would accommodate the various diameters of        the tooth buds 120 and overlying gingival tissue 122        thicknesses.    -   Intra-operative temperature sensing (shown as being performed by        a linear array of temperature sensors 144 in FIG. 8) is        preferably provided at or near the apex of the ablation probe        tip 108 (assuming placement in the ideal middle of the tooth bud        130 b) and/or along the shaft 145 of the probe tip 108.        Temperature sensors 144 provide core temperatures for feedback        control purposes (so that the operator can monitor the        temperature and/or for software feedback control loops and        emergency shutdown) and/or for safety controls to reduce or        eliminate collateral tissue damage. Intra-operative tissue        temperature is preferably measured, both to assure complete        ablation and to prevent over-heating of tissues; this may        require additional set up data or programming. If temperature        sensors 144 are used, the appropriate ablation probe tip 108        preferably will result in the intra-operative placement of the        effective center of ablation 130 a of the ablation probe tip 108        into the targeted middle of the tooth bud 130 b±1.0 mm.

Stent 110

The at least one custom surgical stent 110 (also referred to as a “stent110” or a “surgical stent 110”) has at least one surgical guide 112(also referred to as “guides 112” or “ablation probe tip guides 112”).Two surgical stents 110 would be used, for example, if both upper andlower tooth buds 120 were to be ablated. The surgical stents 110 aredesigned to seat in a patient's mouth and may be supported by at leastone tooth (a tooth-supported surgical stent), soft tissue (a softtissue-supported surgical stent), and/or bone (a bone-supported surgicalstent). If the surgical stent 110 is supported by more than one ofthese, it could be considered a combination-supported surgical stent.Preferred surgical stents 110 may “snap” into the mechanical undercutsinherent in the patient's erupted teeth. A surgical stent 110 would havemore than one surgical guide 112 if more than one tooth bud were to beablated on either the upper or lower jaw.

The surgical stents 110 and the guides 112 therein are used to controlboth the pre-defined angle (φ) and the pre-defined depth (x) of theablation probe tip 108 in order to assure that the ablation probe tip'seffective center of ablation 130 a is in the middle of the tooth bud 130b±0.5 mm. The pre-defined angle (φ) is primarily controlled by the angleof the surgical guides 112 (the passageways through the stent 110). Thepre-defined depth (x) is primarily controlled by the interaction betweenthe mechanical stop structure 142 of the surgical stent 110 (and/orsurgical guide 112) and the mechanical stop structure 140 of theablation probe tip 108. The operator inserts the ablation probe tip 108at the entry angle (φ) defined by the guide 112 and to the depth (x)limited by the mechanical stop structure 140, 142.

The surgical guides 112 are passageways through the surgical stent (thepassageways being a type of guiding structure). The pre-defined angle(φ) for each passageway (guide 112) is determined by the position of themiddle of the tooth bud 130 b. For example, if the middle of the toothbud 130 b is “slightly forward” the angle (φ) of the passageway (guides112) would be “slightly forward” so that the ablation probe tip 108 isangled “slightly forward” so that the center of ablation 130 a ispositioned substantially at the middle of the tooth bud 130 b. The angle(φ) of the passageway is determined (e.g. calculated) by the softwarebased upon tooth bud volumes determined in pre-surgical volume scanning82. In addition to providing a path through which the ablation probe tip108 accesses the gingival tissue and the tooth bud, the guides 110 mayalso be used to provide access for administering local anesthetic and toprovide access to a tissue trocar 146 (if necessary).

In the shown preferred example, the mechanical stop structure 142 is theupper surface of the surgical stent 110 and/or surgical guide 112. Themechanical stop structure 142 is substantially adjacent to or near thesurgical guide 112. The mechanical stop structure 142, however, could bepositioned at locations of the surgical stent 110 beyond the surgicalguide 112. Alternative preferred mechanical stop structure 142 includesa protrusion on the upper surface or a notch in the upper surface. Thesize and shape of the mechanical stop structure 142 is determined(calculated or designed) by a process that may be implemented assoftware or as a program and is based upon tooth bud volumes determinedin pre-surgical volume scanning 82 as well as the length between theablation probe tip mechanical stop structure 140 and its center ofablation 130 a. For example, if the middle of the tooth bud 130 b is 2.5mm below the surface (determined in pre-surgical volume scanning 82),and the available ablation probe tips 108 have a length (between theirrespective mechanical stop structure 140 and its center of ablation 130a) of 2.4 mm and 2.6 mm, the process (that may be implemented bysoftware or a program) would determine that the 2.6 mm ablation probetip 108 is the appropriate ablation probe tip 108 (the 2.4 mm ablationprobe tip 108 being too short), but that the surgical stent 110 and/orsurgical guide 112 would have to be approximately 0.1 mm thick to makeup the difference or the 2.6 mm ablation probe tip 108 would be able tobe pushed in too far.

FIG. 12 is a flowchart showing the steps of a process (that may beimplemented as one or more software program or subprograms if the shownsteps are divided) that, in part, determines the pre-defined angle (φ)and the pre-defined depth (x) (see steps 200, 210, 212, 214, 216, and218). Using this process, patient volume scans are used to accuratelymanufacture or fabricate custom surgical stents 110 with the correctablation probe tip angle (φ) and depth (x) manufactured into them. Morespecifically, using this process with the volume scans will permitaccurate placement of the distal surgical guides 112 onto the customsurgical stents 110 so that both angle (φ) of insertion and depth (x) ofinsertion of the ablation probe tip 108 are controlled to±0.5 mm,placing the ablation probe tip's effective center of ablation 130 a inthe middle of the tooth bud 130 b.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred stents 110.

-   -   Preferred surgical stents 110 are preferably disposable (e.g.        single-use).    -   Manufacturing or fabricating of the custom surgical stents 110        may be based upon Poly Vinyl Siloxane (PVS) full arch        impressions of the patient's erupted teeth using either        conventional lab fabrication techniques or direct-digital        manufacturing or fabricating techniques. If an operator has a        CBCT unit in his office, it may be possible to directly scan the        PVS impressions and email the volume scan of the impression to        eliminate the need to physically send them to the lab. The        impression materials may include materials other than PVS and        preferably will be contrast-optimized through the addition of        X-ray contrast agents (such as barium or iodine) to provide        optimized volume scans of the dental impression for resolving        the fine surface detail of the teeth and gingival tissue 122.        This unique material would be a radiographic contrast-optimized        dental impression material for high resolution X-ray CT volume        scanning.    -   Preferred surgical stents 110 are preferably made of any        appropriate material including, but not limited to, plastic,        acrylic, or other nontoxic sturdy material suitable for use in a        patient's mouth.    -   One exemplary surgical stent 110 composition may be, for        example, clear acrylic (polymethyl methacrylate). It should be        noted that materials suitable for additive-type manufacturing        (or other direct-digital manufacturing or fabricating        techniques) that resulted in nontoxic sturdy stents would be        preferable.    -   Preferred surgical stents 110 preferably have markings such as        color codes or numbering clearly marking or identifying the        tooth bud numbering sites.    -   Once the surgical stent 110 is seated onto the patient's teeth,        it preferably will remain firmly in place throughout the        surgical phase 90 of the TBA procedure 70.    -   The operator may administer local anesthetic through the guides        112.

Pre-determined Settings 105

The pre-determined settings 105 include, for example, pre-determinedparameter settings 105 a and/or treatment time settings 105 b that areneeded to control (provide instructions to) the generator 104 (alone oras part of an ablation probe unit 102) to provide sufficient ablationmeans 104′ to ablate the tooth bud 120, but not so much as to incursignificant collateral soft tissue damage (e.g. to the gingival tissue122). For example, the pre-determined parameter settings 105 a mightcontrol the quantity and quality ablation means 104′ delivered to thetooth bud 120. The actual pre-determined parameter settings 105 a willbe highly dependent on the type of ablation means 104′ to be delivered.For example, MW and RF ablation means might have parameters relating towavelength and/or frequency, hot tip ablation means might haveparameters relating to temperature, chemical ablation means might haveparameters relating to the strength of the chemical and how fast thechemical is flowing into the tooth bud, and mechanical ablation meansmight have parameters relating to speed.

The pre-determined settings 105 are determined (which includescomputing, calculating, looking up, processing, or otherwisedetermining) by a process (that may be implemented as software or aprogram) based upon tooth bud volumes determined in pre-surgical volumescanning 82. It should be noted that the pre-determined settings 105 maytake into consideration factors other than tooth bud volume including,but not limited to, image recognition programs to measure tooth budlocation, age and size of the patient, and other relevant factors tosuccessfully image the patient for the TBA procedure 70. FIG. 12 is aflowchart showing the steps of a process (that may be implemented as oneor more software program or subprograms if the shown steps are divided)that, in part, determines the pre-determined parameter settings 105 aand/or treatment time settings 105 b (see steps 200, 220, 222, and 224).

The generator 104 (and/or the ablation probe unit 102) may be programmedby the operator and/or technicians at the laboratory and/or factory. Theprogramming may be automatic or manual. “Programming” includes havingthe pre-determined settings 105 pre-entered and/or entering (inputting)the pre-determined settings 105 manually or automatically into thegenerator 104 (and/or the ablation probe unit 102) via operator inputmechanisms. For example, the pre-determined settings 105 may bepreprogrammed into an ablation probe unit 102, transmitted to theoperator in the form of a programming signal (e.g. over the internet tobe downloaded and installed in the ablation probe unit 102 or thegenerator 104), provided in the form of computer-readable media (e.g. adisc or a solid state USB drive), and/or provided as data (or a code)that may be manually entered into the ablation probe unit 102 (or thegenerator 104). Ideally, whichever method of entering/programming theablation probe unit 102 (or the generator 104) is used, operator erroris considered and eliminated as much as possible and appropriate checksare used. Preprogramming and some of the other means for programming theablation probe unit 102 (or the generator 104) with the pre-determinedsettings would help to eliminate operator input errors. Another exampleof means for eliminating errors is that even if the ablation probe unit102 (or the generator 104) is preprogrammed by the laboratory, thepre-determined settings might be displayed to the user for independent“verification” as the user could notice variations from normalpre-determined settings (e.g. the literature provided might provide arange and the operator would notice if the provided pre-determinedsettings 105 fell outside of the range). Yet another example is that thepre-determined settings might be provided as a code that, when input,would only function if it corresponded with a logical setting (e.g. ifthe person's age was also input into the ablation probe unit 102 and thecode was not a logical setting based on the age, the ablation probe unit102 would not function).

The pre-determined settings 105 for each TBA site may be included in theTBA surgical kit as a print out, on a disk or other computer readablestorage media, or with instructions on how to obtain or download theinformation.

The pre-determined ablation means parameter settings 105 a can also bereferred to as “parameter settings 105 a, ” “preferred parametersettings 105 a, ” “optimal parameter settings 105 a, ” “ideal parametersettings 105 a, ” “pre-determined parameter settings 105 a, ”“recommended parameter settings 105 a, ” or “prescribed parametersettings 105 a l .”

Tissue Trocar 146

If the ablation probe tip 108 is not self-introducing, at least onesharp instrument (that is preferably disposable) such as a tissue trocar146 (and sometimes a plurality of tissue trocars) may be used by theoperator to introduce (initially create) the access opening through thethick attached gingival tissue 122 that overlays third molar tooth buds120. The tissue trocar tips are preferably sharp enough to be pushedand/or punched through the gingival tissue 122 into the base of thetooth bud. The diameter of the tissue trocar 146 rapidly increases up to100% of the size of the ablation probe tip 108. After the tissue trocar146 has created the access opening, the tissue trocar 146 is removed andthe ablation probe tip 108 is immediately placed into the accessopening.

TBA Surgical Kit

The TBA surgical kit is a package that includes the majority of thenecessary components and information for the surgical phase 90 of theTBA procedure 70. The TBA kit will be assembled (or the assembly will becompleted) based on the patient's impressions and volume scans.Preferably, the TBA surgical kit has attractive packaging.

-   -   An exemplary TBA surgical kit may consist of (a) a custom        surgical stent 110 for each arch as required, (b) at least one        ablation probe tip 108 labeled its respective surgical site, (c)        at least one tissue trocar 146 (if necessary), and (d)        pre-determined settings 105 for each TBA site along with patient        and operator identification.    -   If feedback controls are a part of the ablation probe tip        design, then the correct in situ tissue temperature settings are        preferably computed and supplied with the ablation probe tips        108 as part of the surgical kit.    -   The generator 104 and/or the hand pieces 106 are standard        equipment in a dental office and/or can be purchased separately.    -   The ablation probe tips 108 may be pre-purchased (or extras may        be kept in a practitioner's office) in which case the TBA        surgical kit would provide a part number or other identifying        information so that the practitioner would know which ablation        probe tip 108 should be used with each guide 112.    -   It should be noted some of the components may not be part of the        physical TBA surgical kit. For example, the pre-determined        settings 105 may be provided electronically.

The TBA Procedure 70

Using the TBA procedure 70 described herein, the effective center ofablation 130 a of the ablation probe tip 108 can be positioned at apre-defined angle (φ) and pre-defined depth (x) so that the ablationprobe tip's effective center of ablation 130 a is positionedsubstantially in the “middle” of the tooth bud 130 b withinapproximately 50%, 25%, or even less than 10% of the average diameter ofthe tooth bud 120. This is extremely accurate as compared to previousprocedures.

FIG. 4 shows the steps and/or phases in an exemplary preferred TBAprocedure 70: (1) routine screening and diagnosis 72; (2) pre-surgicalscanning 82 (including taking impressions 84 and using scanningtechnology 86); (3) assembling a TBA surgical kit 88 (includingpre-determined settings 105 and a stent 110); (4) operator delivery ofthe surgical phase 90 of the TBA procedure 70 (shown in more detail inFIGS. 11); and (5) post-surgical steps 98. Steps (2) and (3) are alsoreferred to jointly as the pre-surgical phase 80 during which steps aretaken to create (including calculating, manufacturing, fabricating,selecting, and/or assembling) components of the TBA system 100 and/orthe TBA surgical kit to be provided to the operator. Step (4) is alsoreferred to as the surgical phase 90 of the TBA procedure 70 duringwhich the steps shown in FIG. 11 are taken to ablate tooth buds 120.

(1) Screening Phase 72

Routine screening using panographic or intra-oral X-ray imagingtechniques is necessary to identify the presence of forming tooth buds120 starting at age 6 through age 12 because of the wide range of agesinvolved with the formation of third molar tooth buds 120.

(2) Impressions and Scanning of Pre-Surgical Phase 80

Once third molar tooth buds 120 have been identified to be present usingstandard screening methods (screening phase 72), the next step is topre-operatively measure the precise three-dimensional location andvolume of each third molar tooth bud 120. This may be practicallyaccomplished using scanning technology 86 (e.g. computed tomographyvolume scanning such as CBCT). Scanning technology 86 can be used toaccurately generate the necessary three-dimensional volume scans(computed tomography volume scans) and measurements±0.2 mm using, forexample, the distal side of erupted first molars as durable physicallandmarks (although it is possible to use soft tissue over bone aslandmarks). The scanning technology 86 produces tooth bud size andposition data 86′ (also referred to as “volume scans” and/or“measurements”) that is provided for the step of producing the TBAsurgical kit 88. The tooth bud size and position data 86′ may beprovided as a scanning technology file that can be any data filegenerated by the scanning technology 86 with the data necessary tomanufacture or fabricate a stent 110. One exemplary type of scanningtechnology file is a three-dimensional computer aided design (CAD) file.

An impression 84 of the patient's teeth and gum tissue (gingival tissue122) is made using standard impression materials such as PVS-typeimpression material (although other impression materials can be used).The impressions 84 are then processed and/or scanned using scanningtechnology (e.g. CBCT imaging by dentists and/or CT imaging in thelaboratory), and the resulting volume scan of the impression is emailed(or otherwise transmitted or delivered) to a laboratory and/or factorywhere the volume scan is used for manufacturing or fabricating. It isstill possible to physically mail the PVS dental impressions 84 to thedesignated laboratory and/or factory for manufacturing or fabricating.

Although the scanning technology is discussed primarily in terms ofcomputed tomography volume scanning (e.g. CBCT technology), alternativescanning technologies including, but not limited to, ultrasound scanningtechnologies and future developed scanning technologies are included inthe scope of the invention. Specialty software or programs may be usedwith the scanning technology 86 to accomplish the purpose describedherein. It should be noted that alternative scanning technology 86(including future developed scanning technology) may be used if it isable to accurately generate the necessary three-dimensional volume scansand measurements±0.2 mm using the distal side of erupted first molars(or other landmarks) as durable physical landmarks. It should be notedthat alternative scanning technology (including future developedscanning technology) may also be used as long as two- orthree-dimensional scanning results in the positioning of the effectivecenter of ablation 130 a within approximately 50%, 25%, or even lessthan 10% of the average diameter of the tooth bud 120.

(3) Assembling a TBA Surgical Kit 88

The pre-surgical phase 80 of the TBA procedure 70 includes assembling aTBA surgical kit 88. This step of assembling a TBA surgical kit 88preferably includes computing pre-determined settings 105 andmanufacturing or fabricating the stent 110 based on tooth bud size andposition data 86′ obtained from the scanning technology 86. The processof computing pre-determined settings 105 may be controlled by a process(that may be implemented by software or a program). The process ofmanufacturing or fabricating the stent 110 may also be controlled by aprocess (that may be implemented by software or a program).

After the impressions 84 are processed and/or scanned and the tooth budsize and position data 86′ is obtained, the process of manufacturing orfabricating the stent 110 may be carried out using direct-digitalmanufacturing or fabricating techniques similar to the processes usedfor manufacturing or fabricating implant surgical stents directly fromCBCT scans (e.g. the processes used for fabricating SurgiGuideTM andother implant surgical guides) and the process used for manufacturing orfabricating orthodontic aligners (e.g. orthodontic aligners made byAlign Technology or ClearCorrect). The direct-digital manufacturing orfabricating techniques, however, use the tooth bud size and positiondata 86′ to position and angle the surgical guides 112 on the distalaspects of the surgical stents 110 and use the erupted first molars asthe primary landmark for positioning. Although manufacturing orfabricating will usually be done remotely in a laboratory and/orfactory, it is possible that larger clinics will have the ability tomanufacture or fabricate surgical stents 110 in their own in-houselaboratory and/or factory.

Direct-digital manufacturing or fabricating techniques can be defined asany manufacturing or fabricating process that creates physical partsdirectly from data (e.g. three-dimensional CAD files) usingmanufacturing or fabricating techniques including, but not limited to,surgical stent manufacturing or fabricating technologies, rapidturn-around fabrication technologies, computer aided manufacturing(CAM), technologies using CAD, computer numerical control (CNC) milling,“additive” manufacturing, direct-digital laser stereolithographyfabrication, “3-D printing,” or any other manufacturing or fabricatingmeans known or yet to be discovered that is capable of using the resultsgenerated by scanning to manufacture or fabricate the custom surgicalstents. Because of the possibility for the integrated use ofdirect-digital volume scanning of impressions, low manufacturing costs,and rapid turn around times, use of direct-digital manufacturing orfabricating techniques is one preferred manufacturing or fabricatingtechnique, but more traditional manufacturing or fabricating techniquesthat require more labor intensive manual laboratory processing couldalso be used.

At least one process that may be implemented as software or as at leastone program (e.g. custom software enhancements in the CBCT software)will preferably assist in the direct-digital manufacturing orfabricating of the surgical stents 110 and define (and/or compute orcalculate) the pre-determined settings 105. This process would includedefining (and/or computing or calculating) positioning and entry angledata required for placement of the ablation probe tip's effective centerof ablation 130 a into the middle of the targeted tooth bud 120.Additionally, tooth bud volumes are preferably computed (possibly usingthe scanning technology) and then the tooth bud volumes are used todetermine the pre-determined settings 105 necessary to effecttherapeutic ablation. Tooth bud volumes will generally range from 4.0 mmto 12.0 mm in diameter at ages 6-12. The ablation means 104′ andtreatment times are preferably considered in the calculations. Companiesthat make CBCT imaging equipment promote the development ofprocedure-specific software in order to gain end-user acceptance oftheir imaging systems in the market place. The process may usecalculations and/or look-up charts (e.g. based on experimental data) fordetermining the necessary settings.

FIG. 12 is a flowchart showing the steps of a process (that may beimplemented as one or more software programs or subprograms if the shownsteps are divided) for manufacturing or fabricating custom surgicalstents 110 and/or determining the pre-determined parameter settings 105a and/or treatment time settings 105 b. As shown, the process beginswith receiving pre-operative measurements of the precisethree-dimensional location and volume of each third molar tooth bud andinformation regarding the ablation probe unit including its ablationmeans capabilities 200. To make the stents 110, the process wouldpreferably include the following steps: (a) determining an entry pointfor an ablation probe tip 210; computing the angle and depth of the pathbetween the entry point and the middle of a tooth bud 212; (b) takinginto consideration the depth of the path, creating or selecting anablation probe tip having the proper distance between its mechanicalstop and its center of ablation so that the ablation probe tip will beinserted so that its center of ablation will be in the middle of thetooth bud 214; (c) taking into consideration the angle and depth of thepath and the thickness of the surgical stent, computing the surgicalguide pathway through which the ablation probe tip will be inserted sothat its center of ablation will be in the middle of the tooth bud 216;and (d) providing the surgical guide pathway as output for the creationof a surgical stent with surgical guides 218. To calculate thepre-determined parameter settings 105 a and/or treatment time settings105 b, the process would preferably include the following steps: (a)taking into consideration the information regarding the ablation probeunit including its ablation means capabilities, determining the properpower settings 220; (b) taking into consideration the informationregarding the ablation probe unit including its ablation meanscapabilities, determining the proper time settings 222; and (c)providing the proper power and time settings as output for use inprogramming the ablation probe unit or generator 224.

As described above, in addition to the surgical stent(s) 110 and thepre-determined settings 105, the TBA surgical kit may include at leastone ablation probe tip 108 labeled for its respective surgical site, atleast one tissue trocar 146 (if necessary), and patient and operatoridentification.

The TBA surgical kit is provided to the operator.

(4) Surgical Phase 90

FIGS. 6-10 show graphically, and FIG. 11 shows as a flow chart, thesurgical phase 90 of the TBA procedure. The surgical phase 90 may beperformed by a dental operator (dental practitioner) in his office (e.g.a pediatric office and/or general dental office) under normal officeconditions. At this point, the generator 104 has been programmed withthe pre-determined settings 105 and normal surgical procedures have beenfollowed. The generator 104 is preferably tuned so that the ablationmeans 104′ is set to ablate the small, substantially spherical ablationvolumes of third molar tooth buds 120 in order to minimize (or possiblyeliminate) collateral osseous and soft tissue damage, especially damageto adjacent second molars that are likely not yet erupted. Further, thesurgical phase 90 uses single-use and disposable delivery systems thatuse components designed for intra-oral use.

Summarily, as shown in FIG. 11, the first step is physically seating asurgical stent 160 in a patient's mouth. Next, the operator makes anaccess path at the at least one tooth bud surgical site 162. Theoperator also places the ablation probe tip so that the center ofablation is in the middle of a tooth bud at the at least one tooth budsurgical site (using the custom surgical stent to guide the placement)164. It should be noted that if the ablation probe tip is“self-introducing,” the step of making an access path and the step ofplacing the ablation probe tip may occur simultaneously. Then, the atleast one tooth bud is at least partially ablated 166 and the ablationprobe tip is removed from the tooth bud 168. These and other exemplarysteps are detailed in the following paragraphs.

The operator preferably starts the surgical phase 90 by placing thesurgical stent 110 into place onto the patient's teeth prior toadministering local anesthetic to the surgical site. The localanesthetic will then be administered through the surgical stent 110 andguides 112 that are in close approximation with the gingival tissue 122,thus reducing the amount of anesthetic necessary because of the preciseplacement of anesthetic agent. Achieving local anesthesia in thisprocedure will be easier than anesthetizing lower permanent molar teethfor routine fillings since only soft tissues, which will be 8.0 mm to15.0 mm deep, are involved.

The step of physically seating a surgical stent 110 may also includephysically seating the surgical stent in a patient's mouth, physicallyseating the surgical stent on a patient's erupted teeth, physicallyseating the surgical stent on at least one tooth in a patient's mouth,physically seating the surgical stent on a patient's soft tissue,physically seating the surgical stent on a patient's bone, or acombination of the above steps (e.g. physically seating the surgicalstent on a patient's teeth, soft tissue, and bone).

Once the custom surgical stent 110 is in place and the patient is fullyanesthetized, the operator then mechanically gains access to the toothbud 120 through the stent surgical guides 112 by creating (introducing)a small surgical access path opening through the gingival tissue 122approximately 0.1 mm to 2.0 mm (and more particularly 0.5 mm to 1.0 mm)in diameter using tissue trocars. If the ablation probe tips 108 aredesigned to be strong enough and sharp enough to act as“self-introducing” probe tips, they can be used to introduce thesurgical access path. On the other hand, if the ablation probe tipitself is not self-introducing, the surgical access path may beintroduced using a then there will be no need for separate tissue trocar146.

It should be noted that the surgical access path is preferably anincision, a puncture, or a hole through the gingival tissue 122. If aself-introducing probe tip is used, the surgical access path hassubstantially the same diameter as the ablation probe tip 108. If theprobe tip is not self-introducing, the surgical access path may be asutureless puncture (0.1 mm to 2.0 mm in diameter) or, moreparticularly, a sutureless puncture (0.5 mm to 1.0 mm in diameter).Alternatively, a trocar “punch” may be made through tough gingivaltissue 122. Regardless of the procedure used to introduce the surgicalaccess path, using a surgical access path to gain access or allowplacement of the ablation probe tips 108 to the tooth bud 120 does notkill, damage, or otherwise cause necrosis to the surrounding softtissues (e.g. gingival tissues 122). This can be compared to otherprocesses such as coring, boring, cutting, electrosurge ablating, orother invasive procedures that kill, damage, and/or otherwise causenecrosis to the soft tissue to which the invasive procedure has beenapplied. Although the preferred procedures for introducing the surgicalaccess path might kill individual cells, the soft tissue (the gingivaltissue 122) does not become necrosed because the tissue is a collectionof cells that can heal itself.

As shown in FIGS. 6 and 7, the next step in the surgical phase 90 is toinsert the designated ablation probe tip 108 through the surgical stent110 and into the tooth bud space until it is mechanically “stopped” inorder to position the probe to the prescribed depth (which would be thepre-defined depth). The surgical stent 110 and its surgical guides 112are used to control the angle (φ) and depth (x) of the ablation probetip 108 so that the effective center of ablation 130 a of the ablationprobe tip is in the middle of the tooth bud 130 b. It should be notedthat the effective center of ablation 130 a for any given ablationtechnology does not necessarily correspond with the tip of the ablationprobe. For instance, microwave ablation probes have windows or slotsthat may be 0.5 mm to 2.0 mm from the tip depending on the frequency ofthe wavelength used. Cryoablation probes have their center of ablationroughly in the middle of the probe, depending on the design andrefrigerant used. A mechanical stop structure 140 on the ablation probetip 108 preferably seats firmly onto the mechanical stop structure 142of the surgical stent guide 112 to prevent over extension of theablation probe tip 108.

FIG. 8 shows embedded temperature sensors 144 (or other types offeedback control mechanisms) that may be used during the ablationprocess. An independent feedback process using the temperature sensors144 is preferable for this clinical procedure. Use of temperaturesensors 144 along with monitoring probe impedance characteristics andpercentage of reflected energy in RF/MW circuits will provide “go/no go”output for the clinician. Control algorithms are preferably used toaccelerate initial ablation means 104′ input followed by lower-leveltemperature maintenance for a defined period of time with independentconfirmation that results in a fast process while simultaneouslyassuring complete tooth bud ablation.

FIG. 9 shows the actual ablation process. Activation of the ablationprobe unit 102 to perform the ablation process is executed according tothe pre-determined settings 105. Activation of the ablation probe unit102 causes the generator 104 to provide the ablation means 104′ thatpasses through the hand piece 106 and the ablation probe tip 108 andinto the tooth bud 120. This step of at least partially ablating thetooth bud is preferably accomplished without ablating any surroundinggingival tissue (although a minimal amount of surrounding gingivaltissue may be ablated as an accidental byproduct of the step). This canalso be thought of as the activation of the ablation probe unit 102creating a zone of ablation that resides predominantly or completelywithin the tooth bud 120. The feedback control mechanisms 144 assuresuccessful delivery of adequate ablation means 104′ to ablate the toothbud 120 while minimizing damage to adjacent osseous and soft tissues by,for example, eliminating over-heating. Given the small tissue volumesinvolved for pediatric patients, activation using an RF ablation means104′ would have an ablation time that is preferably less than three (3)minutes and activation using an MW ablation means 104′ would have anablation time that is preferably less than thirty (30) seconds.

FIG. 10 shows the ablation probe tip 108 being removed from the nowablated tooth bud 120′. As shown in this figure, any access path createdby the procedure rapidly closes.

(5) Post-Surgical Phase 98:

After the surgical phase 90, the patient may have follow-up including,but not limited to, post-surgical instructions and, if necessaryfollow-up care and screening.

Post-surgical instructions that may be given to parents includes thefollowing: kids can go out and play immediately unless they weresedated, no post-surgical pain medication is necessary, bleeding (ifany) will be gone in minutes, and post-surgical X-ray screening may benecessary at patient's next routine 6-month hygiene cleaning appointmentto verify full ablation.

Simulated TBA Procedure 70

The following paragraphs, along with FIGS. 13-29, detail an exemplarysimulated TBA procedure 70 including routine screening and diagnosis 72,the pre-surgical phase 80, and the surgical phase 90. In several ofthese figures, a patient's mouth 124 (with gums 122 and teeth 126) isshown that looks like a stone model, but it should be understood thatunless otherwise specified the shown mouth 124 would be a live patient'smouth.

As shown in FIG. 4, the TBA procedure begins with routine screening anddiagnosis 72. FIG. 13 is a panographic X-ray showing a patient whosethird molar tooth buds 120 in the #17 & #32 positions are treatable by aTBA procedure 70. FIG. 14 is a pre-operative CBCT scan (although othertypes of volume scanning could be used) of a patient. In a realprocedure, the volume scan would be taken of the specific patient onwhom the TBA procedure 70 is being performed. This CBCT “reconstructed”panographic scan has a 1.0 mm scale along its bottom edge. FIG. 15 is aseries of CBCT volume scan cross-sections showing successive 1.0 mmslices through both #17 and #32 in 1.0 mm increments. Each X-raycorresponds to 1.0 mm locations along the scale of FIG. 14. Theleft-side scale is 1.0 mm vertically. The maximum tooth bud diametersare measured to be 8.0-9.0 mm.

FIG. 16 shows a pre-operative upper-arch impression 84 being taken ofthe simulated patient's mouth 124 (shown as a stone model for clarity,but an impression 84 would be taken of the patient himself) using animpression tray 128. It is assumed that all four tooth buds of thewisdom teeth are present in the simulated patient. FIG. 17 is across-sectional view of the upper-arch impression 84 being taken of asimulated patient. FIG. 18 shows the completed upper-arch impression 84.A similar process would be performed to manufacture or fabricate apre-operative lower-arch impression 84. At this time the practitionermay send impressions 84 and volume scan data to a laboratory and/orfactory for processing.

The laboratory and/or factory uses the impressions 84 and volume scandata (scanning technology file) to create (including calculating,manufacturing, fabricating, selecting, and/or assembling) components ofthe TBA system 100 (including the surgical stents 110 and thepre-determined settings 105). The surgical stents 110 and thepre-determined settings 105 and other components are then assembled intothe TBA surgical kit to be provided to the operator.

FIG. 19 shows the completed upper-arch impression 84, along with a stonemodel 85 that will serve as a “positive” for manufacturing orfabricating a surgical stent 110 for that patient's upper-arch.Alternatively, when using stereolithography manufacturing to manufactureor fabricate surgical stents 110, the impressions 84 can be computedtomography (“CT”) scanned to digitize as an alternative to makingphysical intermediates. The CT volume scan file (scanning technologyfile) can then be emailed (or otherwise directly transmitted) for directmanufacturing or fabricating. Alternatively, the practitioner may handlethe processing in-house.

FIG. 20 is a CBCT scan with notations showing the measurement of theperpendicular angle of entry into the tooth bud 120. The measurement isbased on the distal aspect of the molar and the occlusal bite plane ofthe teeth. FIG. 21 is a series of X-rays with notations showing themeasurement of the lateral angle of entry. The measurement is determinedrelative to the vertical axis in order to avoid the jaw's boneyinterferences during surgical placement of the ablation probe unit 102.FIG. 22 is a CBCT scan with highlights showing the computed volume ofeach tooth bud 120. CBCT volume data is used to determine and/orcalculate the pre-determined settings 105.

FIG. 23 shows the resulting surgical stent 110 that will be placed in apatient's mouth 124. The shown stent has two surgical guides 112 basedupon the location of the patient's two tooth buds to be ablated.

The surgical stent(s) 110 and the pre-determined setting(s) 105 areprovided to the operator along with the rest of the TBA surgical kit.

Prior to the surgical phase 90 of the TBA procedure 70, the ablationprobe unit 102 and/or the generator 104 should be set up so that atleast one pre-determined setting 105 is correctly entered for at leastone tooth bud 120 with safety interlocks carefully considered. (Thepre-determined settings 105 may all be entered prior to the surgicalphase 90 or they may be entered one at a time.) The surgical phase 90 ofthe TBA procedure 70 may then be performed.

FIG. 24 shows topical anesthetic 87 being applied to the base of thesurgical guide 112 (FIG. 24) prior to the surgical stents 110 beingseated in a patient's mouth 124.

FIG. 25 shows the surgical stent 110 being seated on the upper-arch ofthe simulated patient's mouth 124 (shown as a stone model for clarity).This process would be repeated on the lower-arch of the simulatedpatient.

FIG. 26 shows a local anesthetic being injected 89 into each sitethrough a surgical guide 112 of the stent 110.

FIG. 27 shows a tissue trocar 146 being used to create an access paththrough the gingival tissue 122 to the base of each tooth bud 120. Thetissue trocar 146 is only necessary if self-introducing ablation probetips 108 are not used.

FIG. 28 shows an ablation probe tip 108 with mechanical stop structure140′ (shown as a shoulder) being inserted through the surgical guide112. This would be similar to the position of the ablation probe tip 108in FIG. 6.

FIG. 29 shows the ablation probe tip 108 positioned through the surgicalguide 112 and into the tooth bud 120 through the surgical guide 112 sothat the ablation probe tip's effective center of ablation 130 a is inthe middle of each tooth bud 120. This would be similar to the positionof the ablation probe tip 108 in FIG. 7.

The ablation means 104′ is delivered in this position (FIG. 9). Theablation means 104′ is delivered based on the pre-determined settings105 (e.g. times, intensities, and other prescribed settings unique toeach tooth bud).

The ablation probe tip 108 would then be removed and the processrepeated at the site of each tooth bud 120. Once the entire surgicalphase 90 is complete, the surgical stents 110 are removed.

Finally, the dental practitioner or an assistant provides post-surgicalinstructions to the patient or a caregiver of the patient.

Alternative Scanning and Fabrication of Custom TBA Surgical Kits

An alternative to the pre-surgical phase 80 of the TBA procedure 70described above includes simultaneous three-dimensional scanning of bothhard tissues (bone and teeth) and soft tissues (tooth bud 120 andgingival tissue 122). From the information obtained using this uniquesimultaneous three-dimensional scanning, a custom surgical stent 110 maybe manufactured or fabricated. As discussed, the custom surgical stent110 is used in the surgical phase 90 to help with the placement of thecenter of ablation 130 a into a tooth bud 120 that results in toothagenesis.

The simultaneous three-dimensional scanning uses a single scan to obtainboth soft tissue and hard tissue information. Soft tissue informationgenerally does not show on a scan, although progress in volume scanningis improving and this may be possible in the near future. Known andfuture technologies able to provide a scan image of soft tissue areincluded in the scope of this invention. A typical X-ray scan will onlyshow the hard tissue. So to obtain both soft and hard tissue informationusing simultaneous three-dimensional scanning, a dental impression 84 isused that can be viewed on an X-ray. The dental impression 84 is made ofmaterials that are preferably “contrast optimized” for high resolutionX-ray volume scanning. The ideal level of contrast agent in the range of25% to 75% radiopacity (such as barium or iodine based compounds) ismixed into the dental impression materials so that the highest level ofsurface detail can be picked upon when volume scanning the dentalimpression 84. The dental impression 84 is placed in the patient's mouth124 during the X-ray volume scan. The resulting X-ray volume scan imagewould show the tooth distinguished (is visible) and the dentalimpression 84 distinguished (is visible) and the void therebetween wouldbe the soft tissue and would therefore be “visible.” The resulting X-rayvolume scan with both hard and soft tissue information may then be usedto formulate the custom stent 110 used in the surgical phase 90described herein. In other words, an X-ray volume scan image isgenerated in which hard tissue (e.g. a tooth) is visible hard tissue andthe dental impression 84 is a visible dental impression and soft tissue(e.g. gingival tissue 122) is “visible” as the space between the visiblehard tissue and the visible dental impression.

One separate preferred pre-surgical phase 80 of the TBA procedure 70preferably includes using X-ray volume scans of dental impressions 84 tomanufacture or fabricate surgical stents 110. The X-ray volume scan ofthe dental impression 84 is “super imposed” over the patient X-rayvolume scan (e.g. CBCT scanning) using the dental hard tissues (theteeth) to “snap” the two volume scans together into an accurate overlayso that soft tissues of the mouth (which cannot be X-ray volume scanneddirectly) are accurately defined for the surgical stent manufacturing orfabricating (which must take into account the soft tissue and teeth) andprobe positioning (which must take into account the tooth budpositioning from the patient's CBCT scan).

One separate preferred pre-surgical phase 80 of the TBA procedure 70preferably includes using dental impression materials that are “contrastoptimized” for high resolution X-ray volume scanning that is then usedto manufacture or fabricate surgical stents 110. The ideal level ofcontrast agent (such as barium or iodine based compounds) is mixed intothe dental impression materials so that the highest level of surfacedetail can be picked upon when CT volume scanning the dental impression84.

Alternative Procedures and Systems

Separate preferred surgical procedures preferably include the ablationof “non-tooth” bud lesions or tumors of the maxilla or mandible. In sucha situation, a custom stent would be manufactured or fabricated withguides to guide an ablation probe tip 108 to such a lesion or tumorlocated at least one lesion or tumor surgical site. The process couldthen be used to ablate such lesion or tumor.

Separate TBA surgical procedures preferably include the use ofultrasound scanning with combined ultra-high energy ultrasound ablationbut without the use of a surgical stent for transgingival tooth budablation that results in tooth agenesis. This can be described as directultrasound scanning with ultra-high energy ultrasound built into thesame scanning head.

Comparison To The Silvestri Study

As set forth in the Background section of this document, the articleentitled “Selectively Preventing Development Of Third Molars In RatsUsing Electrosurgical Energy” by Silvestri et al. describes a pilotstudy that tests the hypothesis that third molars can be selectivelyprevented from developing. The results of the Silvestri study were mixedat best, with only ten rats out of thirty-three showing the desiredresult of no intraoral or radiographic evidence of third molardevelopment. One reason that the Silvestri process was not successfulmay have had to do with the fact that the Silvestri process was inexact.For example, the Silvestri process relies on molds taken from molds ofthe mouths of euthanized rat pups rather than using molds fabricated forthe rat pup on which the procedure was to be performed. The presentinvention uses the patient's mouth on which the procedure is to beperformed. Another way in which the Silvestri process was inexact wasthat the Silvestri process did not locate the forming tooth bud 120.More specifically, the Silvestri process did not locate or determine thelocation of the forming tooth bud 120 pre-operatively relative to thelandmarks that he used. Silvestri even states “. . . whenelectrosurgical energy is applied near the invisible tooth anlage in thetiny mouth of newborn rats, the effects of the electrosurgical energycannot be nearly as local or precise. The embryonic tooth-formingtissues of the third molar [lay] fractions of a millimeter below theoral mucosa and cannot be seen. As a result, it was not possible topredictably protect and isolate the vulnerable developing bone from theenergy and heat of the electrosurgical energy. The result was arelatively large, unpredictable area of tissue damage during treatmentand a wide range of bony developmental effects seen after the rats wereeuthanized.” The TBA procedure 70 described herein can be distinguishedfrom the Silvestri procedure in several ways including for example, that(1) the TBA procedure 70 described herein is a minimally invasiveprocedure consisting of introducing a surgical access path at each toothbud surgical site as opposed to the boring, killing, and damagingprocedure described by Silvestri, (2) the TBA procedure 70 describedherein is performed in such a manner that it can be described as exact(e.g. using the patient's mouth as the mold for manufacturing orfabricating the surgical stent 110, taking exact measurements of thepatient's mouth (including the position of the tooth bud 120), and usingcalculated parameter and time settings 105 b) as opposed to theSilvestri procedure that can be described as inexact, and (3) the TBAprocedure 70 described herein can predictably ablate tooth buds 120 asopposed to the Silvestri procedure that was essentially unpredictableand could never, under any circumstances, be considered for treatinghuman patients.

Flow Charts

FIGS. 4, 11, and 12 are flow charts illustrating processes, methods,and/or systems. It will be understood that at least some of the blocksof these flow charts, components of all or some of the blocks of theseflow charts, and/or combinations of blocks in these flow charts, may beimplemented by software (e.g. coding, software, computer programinstructions, software programs, subprograms, or other series ofcomputer-executable or processor-executable instructions), by hardware(e.g. processors, memory), by firmware, and/or a combination of theseforms. As an example, in the case of software, computer programinstructions (computer-readable program code) may be loaded onto acomputer (or on a special purpose machine such as a volume scanner orscanning technology) to produce a machine, such that the instructionsthat execute on the computer create structures for implementing thefunctions specified in the flow chart block or blocks. These computerprogram instructions may also be stored in a memory that can direct acomputer to function in a particular manner, such that the instructionsstored in the memory produce an article of manufacture includinginstruction structures that implement the function specified in the flowchart block or blocks. The computer program instructions may also beloaded onto a computer (or on a special purpose machine such as a volumescanner or scanning technology) to cause a series of operational stepsto be performed on or by the computer to produce a computer implementedprocess such that the instructions that execute on the computer providesteps for implementing the functions specified in the flow chart blockor blocks. The term “loaded onto a computer” also includes being loadedinto the memory of the computer or a memory associated with oraccessible by the computer (or on a special purpose machine such as avolume scanner or scanning technology). The term “memory” is defined toinclude any type of computer (or other technology) -readable mediaincluding, but not limited to, attached storage media (e.g. hard diskdrives, network disk drives, servers), internal storage media (e.g. RAM,ROM), removable storage media (e.g. CDs, DVDs, flash drives, memorycards, floppy disks), and/or other storage media known or yet to bediscovered. The term “computer” is meant to include any type ofprocessor, programmable logic device, or other type of programmableapparatus known or yet to be discovered. Accordingly, blocks of the flowcharts support combinations of steps, structures, and/or modules forperforming the specified functions. It will also be understood that eachblock of the flow charts, and combinations of blocks in the flow charts,may be divided and/or joined with other blocks of the flow chartswithout affecting the scope of the invention. This may result, forexample, in computer-readable program code being stored in whole on asingle memory, or various components of computer-readable program codebeing stored on more than one memory.

Additional Information

It is to be understood that the inventions, examples, and embodimentsdescribed herein are not limited to particularly exemplified materials,methods, and/or structures. Further, all publications, patents, andpatent applications cited herein, whether supra or infra, are herebyincorporated by reference in their entirety.

Please note that the terms and phrases may have additional definitionsand/or examples throughout the specification. Where otherwise notspecifically defined, words, phrases, and acronyms are given theirordinary meaning in the art. The following paragraphs provide some ofthe definitions for terms and phrases used herein.

-   -   The terms “fabricating” and/or “manufacturing” include any        suitable means of making a component (e.g. stent 110). Although        the terms are used together throughout most of the specification        (e.g. “manufacturing or fabricating”), the absence of one term        or another is irrelevant because they are used herein        synonymously.    -   The terms “proper,” “correct,” “optimal,” and “ideal,” are        relative and may become more accurate as technology is        developed. For example, when used in terms of the pre-defined        angle (φ) and pre-defined depth (x) that are calculated and/or        prescribed (e.g. the “proper angle and depth,” the “correct        angle and depth,” the “optimal angle and depth,” or the “ideal        angle and depth”), these phrases are meant to include the best        possible angle and depth that is calculated using the best        available information and technology.    -   The terms “provide” and “providing” (and variations thereof) are        meant to include standard means of provision including        “transmit” and “transmitting,” but can also be used for        non-traditional provisions as long as the data is “received”        (which can also mean obtained). The terms “transmit” and        “transmitting” (and variations thereof) are meant to include        standard means of transmission, but can also be used for        non-traditional transmissions as long as the data is “sent.” The        terms “receive” and “receiving” (and variations thereof) are        meant to include standard means of reception, but can also be        used for non-traditional methods of obtaining as long as the        data is “obtained.”

It should be noted that the terms “may” and “might” are used to indicatealternatives and optional features and only should be construed as alimitation if specifically included in the claims. It should be notedthat the various components, features, steps, phases, or embodimentsthereof are all “preferred” whether or not it is specifically indicated.Claims not including a specific limitation should not be construed toinclude that limitation.

It should be noted that, unless otherwise specified, the term “or” isused in its nonexclusive form (e.g. “A or B” includes A, B, A and B, orany combination thereof, but it would not have to include all of thesepossibilities). It should be noted that, unless otherwise specified,“and/or” is used similarly (e.g. “A and/or B” includes A, B, A and B, orany combination thereof, but it would not have to include all of thesepossibilities). It should be noted that, unless otherwise specified, theterm “includes” means “comprises” (e.g. a device that includes orcomprises A and B contains A and B but optionally may contain C oradditional components other than A and B). It should be noted that,unless otherwise specified, the singular forms “a,” “an,” and “the”refer to one or more than one, unless the context clearly dictatesotherwise.

The terms and expressions that have been employed in the foregoingspecification are used as terms of description and not of limitation,and are not intended to exclude equivalents of the features shown anddescribed. This application is intended to cover any adaptations orvariations of the present invention. It will be appreciated by those ofordinary skill in the art that any arrangement that is calculated toachieve the same purpose may be substituted for the specific embodimentshown. It is also to be understood that the following claims areintended to cover all of the generic and specific features of theinvention herein described and all statements of the scope of theinvention which, as a matter of language, might be said to falltherebetween.

What is claimed is:
 1. A method for using a third molar tooth budablation system in a third molar tooth bud ablation procedure forablating a third molar tooth bud, said third molar tooth bud having amiddle, said procedure resulting in the agenesis of said third molar ina human patient, said method comprising the steps of: (a) providing anablation probe unit capable of providing ablation energy; (b) providingan ablation probe tip having a shaft, mechanical stop structure, and acenter of ablation, said center of ablation positioned on said shaft,said ablation probe tip connectable to said ablation probe unit; (c)providing a custom surgical stent with at least one surgical guidecorresponding to at least one third molar tooth bud surgical site, saidat least one surgical guide having guiding structure, said at least onesurgical guide being a passageway through said surgical stent, saidpassageway being sized to guide placement of said ablation probe tiponly at a pre-defined angle, said at least one surgical guide havingmechanical stop structure to limit the depth of said ablation probe tipto a pre-defined depth; (d) guiding said ablation probe tip at saidpre-defined angle using said guiding structure; (e) limiting the depthof said ablation probe tip through said at least one surgical guideuntil there is a mechanical stop between said mechanical stop structureof said at least one surgical guide and said mechanical stop structureof said ablation probe tip; and (f) at least partially ablating saidthird molar tooth bud using said ablation energy when said center ofablation is in the middle of the third molar tooth bud.
 2. The method ofclaim 1, said at least partially ablating said third molar tooth budfurther comprising the step of at least partially ablating said thirdmolar tooth bud without ablating surrounding tissue by seating saidcustom surgical stent in said human patient's mouth such that saidguiding structure guides placement of said ablation probe tip at saidpre-defined angle and said mechanical stop structure limits the depth ofsaid ablation probe tip to said pre-defined depth, said custom surgicalstent remaining in the human patient's mouth while said at least onethird molar tooth bud is being at least partially ablated.
 3. The methodof claim 1 further comprising the step of administering local anestheticby seating said custom surgical stent in the human patient's mouth suchthat said guiding structure guides placement of an anesthetic needle tipat said pre-defined angle, said custom surgical stent remaining in thehuman patient's mouth while said at least one third molar tooth bud isbeing anesthetized.
 4. The method of claim 1 said step of at leastpartially ablating said third molar tooth bud using said ablation energyfurther comprising the step of at least partially ablating said thirdmolar tooth bud using said ablation energy selected from the groupconsisting of: (a) microwave; (b) radio frequency; (c) irreversibleelectroporation; (d) cryoablation; (e) ultra-high intensity ultrasound;(f) laser; and (g) a combination of at least two ablation energies setforth in (a)-(g).
 5. The method of claim 1 said step of at leastpartially ablating said third molar tooth bud using said ablation energyfurther comprising the step of at least partially ablating said thirdmolar tooth bud using microwave ablation.
 6. The method of claim 1 saidstep of at least partially ablating said third molar tooth bud usingsaid ablation energy further comprising the step of at least partiallyablating said third molar tooth bud using radio frequency ablation. 7.The method of claim 1 said step of at least partially ablating saidthird molar tooth bud using said ablation energy further comprising thestep of at least partially ablating said third molar tooth bud usingirreversible electroporation ablation.
 8. The method of claim 1 saidstep of at least partially ablating said third molar tooth bud usingsaid ablation energy further comprising the step of at least partiallyablating said third molar tooth bud using cryoablation.
 9. The method ofclaim 1 said step of at least partially ablating said third molar toothbud using said ablation energy further comprising the step of at leastpartially ablating said third molar tooth bud using ultra-high intensityultrasound ablation.
 10. The method of claim 1 said step of at leastpartially ablating said third molar tooth bud using said ablation energyfurther comprising the step of at least partially ablating said thirdmolar tooth bud using laser ablation.
 11. The method of claim 1 saidstep of at least partially ablating said third molar tooth bud usingsaid ablation energy further comprising the step of at least partiallyablating said third molar tooth bud using chemical ablation.
 12. Themethod of claim 1 said step of at least partially ablating said thirdmolar tooth bud using said ablation energy further comprising the stepof at least partially ablating said third molar tooth bud usingmechanical ablation.
 13. The method of claim 1 said step of at leastpartially ablating said third molar tooth bud using said ablation energyfurther comprising the step of at least partially ablating said thirdmolar tooth bud using hot tip ablation.
 14. The method of claim 1, saidstep of providing a custom surgical stent with at least one surgicalguide corresponding to at least one third molar tooth bud surgical sitefurther comprising the step of providing a custom surgical stent createdbased on measurements of a three-dimensional location and volume of athird molar tooth bud of said human patient, and said custom surgicalstent being created based on calculations of a middle of said thirdmolar tooth bud calculated using said measurements of saidthree-dimensional volume.
 15. The method of claim 1, said step of atleast partially ablating said third molar tooth bud using said ablationenergy occurring after said step of guiding said ablation probe tip andsaid step of limiting the depth of said ablation probe tip.
 16. Themethod of claim 1, said procedure resulting in tooth agenesis.
 17. Themethod of claim 1, said step of providing a custom surgical stentfurther comprising the step of providing a custom surgical stentcontoured to mate with at least one tooth of said human patient.
 18. Themethod of claim 1, said step of providing a custom surgical stentfurther comprising the step selected from the group consisting of: (a) aproviding a tooth-supported custom surgical stent; (b) a providing asoft tissue-supported custom surgical stent; and (c) a providing acombination-supported custom surgical stent in which said surgical stentis supportable by a combination of at least one tooth and soft tissue.19. The method of claim 1, said step of providing a custom surgicalstent further comprising providing a tooth-supported custom surgicalstent.
 20. The method of claim 1, said step of providing a customsurgical stent further comprising providing a soft tissue-supportedcustom surgical stent.
 21. The method of claim 1, said step of providinga custom surgical stent further comprising providing acombination-supported custom surgical stent in which said surgical stentis supportable by a combination of at least one tooth and soft tissue.22. A method for creating a third molar tooth bud ablation systemincluding a custom surgical stent and an ablation probe tip for use in athird molar tooth bud ablation procedure that results in the agenesis ofa third molar in a human patient, said system comprising: (a) measuringa three-dimensional location and volume of a third molar tooth bud ofsaid human patient to obtain three-dimensional location measurements andvolume measurements; (b) calculating a middle of said third molar toothbud using said volume measurements; (c) obtaining said ablation probetip, said ablation probe tip having a shaft and a center of ablation,said center of ablation positioned on said shaft; (d) calculating apre-defined angle to guide said ablation probe tip so that said centerof ablation is in the middle of the third molar tooth bud, thecalculations of said pre-defined angle being based on saidthree-dimensional location measurements and volume measurements; (e)calculating a pre-defined depth to limit the depth of said ablationprobe tip so that said center of ablation is in the middle of the thirdmolar tooth bud, the calculations of said pre-defined depth being basedon said three-dimensional location measurements and volume measurements;and (f) creating said custom surgical stent with at least one surgicalguide corresponding to at least one third molar tooth bud surgical site,said at least one surgical guide having guiding structure, said at leastone surgical guide being a passageway through said surgical stent, saidpassageway being sized to guide placement of said ablation probe tiponly at said pre-defined angle, said at least one surgical guide havingmechanical stop structure to limit the depth of said ablation probe tipto said pre-defined depth.
 23. The method of claim 22, said step ofcreating a custom surgical stent further comprising the step of creatinga custom surgical stent contoured to mate with at least one tooth ofsaid human patient.
 24. The method of claim 22, said step of creatingsaid custom surgical stent further comprising the step selected from thegroup consisting of: (a) a creating a tooth-supported custom surgicalstent; (b) a creating a soft tissue-supported custom surgical stent; and(c) a creating a combination-supported custom surgical stent in whichsaid surgical stent is supportable by a combination of at least onetooth and soft tissue.
 25. The method of claim 22, said step of creatinga custom surgical stent further comprising creating a tooth-supportedcustom surgical stent.
 26. The method of claim 22, said step of creatinga custom surgical stent further comprising creating a softtissue-supported custom surgical stent.
 27. The method of claim 22, saidstep of creating a custom surgical stent further comprising creating acombination-supported custom surgical stent in which said surgical stentis supportable by a combination of at least one tooth and soft tissue.28. A method for using a tooth bud ablation system in a tooth budablation procedure for ablating a tooth bud, said tooth bud having amiddle, said procedure resulting in the agenesis of said tooth bud, saidmethod comprising the steps of: (a) providing an ablation probe unitcapable of providing ablation energy; (b) providing an ablation probetip having a shaft, mechanical stop structure, and a center of ablation,said center of ablation positioned on said shaft, said ablation probetip connectable to said ablation probe unit; (c) providing a customsurgical stent with at least one surgical guide corresponding to atleast one tooth bud surgical site, said at least one surgical guidehaving guiding structure, said at least one surgical guide being apassageway through said surgical stent, said passageway being sized toguide placement of said ablation probe tip only at a pre-defined angle,said at least one surgical guide having mechanical stop structure tolimit the depth of said ablation probe tip to a pre-defined depth; (d)guiding said ablation probe tip at said pre-defined angle using saidguiding structure; (e) limiting the depth of said ablation probe tipthrough said at least one surgical guide until there is a mechanicalstop between said mechanical stop structure of said at least onesurgical guide and said mechanical stop structure of said ablation probetip; and (f) at least partially ablating said tooth bud using saidablation energy when said center of ablation is in the middle of thetooth bud.